Research Responsibilities and Compliance

Informed Consent, Assent and Parental Permission

Informed consent is an essential part of ethical human subjects research.

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve. Institutional Review Boards and investigators are responsible for ensuring that research participants provide informed consent prior to participating in research unless the requirement for informed consent is waived or altered (in non-exempt research) by the IRB.

Review the Policy for the Process and the Elements of Informed Consent

Templates and Guidance

The following templates contain the basic elements of informed consent and are recommended for use to streamline IRB review and ensure that regulatory requirements are met. Study-specific information should be added to the templates using complete sentences in non-technical language. Additional consent template language should be inserted in the designated sections of consent documents, as applicable.

Reading Level

When adding study-specific information to the templates, use simple lay language and an 8th-grade reading level throughout. Use the Flesch-Kincaid score tool in Word to measure the document's reading level.

  • write short, simple, and direct sentences using lay language
  • spell out all abbreviations and acronyms
  • avoid scientific or technical terms

Formatting

  • use 12-point font or larger based on your audience
  • Times New Roman or Arial font is recommended
  • line numbers have been added to aid in the review process and must be removed after the consent has been IRB approved
  • update the template header:
    • IRB Protocol Number – the number assigned by ORRP (e.g., 2023H0156)
    • IRB Approval date – the date of IRB approval, which can be found on your approval letter
    • Version – personal tracking mechanism; dates (e.g., 11/20/2022) or numbers (e.g., 1.2)

Informed Consent Templates

Review the Documentation of the Informed Consent Process Policy

Instructions and Guidance

Online Research Consent Templates

For minimal risk research being conducted online (such as using an online survey host, conducting interviews via a video messaging platform, document collection via e-mail) consent may be obtained via participants reading a script and then agreeing to participate by clicking a link to a survey, a check box formatted by the survey host, etc. This is an example of a script to be read by participants to collect consent for participation in online research. The example provided either includes or prompts information for the required elements of consent as well as additional language specific to participant confidentiality when collecting data online. A consent script must be submitted for IRB review in conjunction with a request for a waiver of consent documentation.

Electronic Signatures for Informed Consent

There are a variety of methods that can be used to obtain and document informed consent that meet the requirements of the university’s electronic signature policy. Some of the methods qualify as a legally valid electronic signature while others would only apply to minimal risk research and require a waiver of consent documentation. Information and guidance on obtaining and documenting electronic consent is provided by the Office of Technology and Digital Innovation.

Verbal Consent and Contact Card Templates

In some research studies, consent may be obtained verbally rather than by using a signed consent form. The consent script example includes all of the required elements of consent and can be tailored with information specific to the study. A verbal consent script must be submitted for IRB review in conjunction with a request for a waiver of consent documentation. The contact card with study-specific and ORRP contact information may be given to participants providing verbal consent.

Parental Permission Templates

The permission of a parent(s) or guardian must be obtained and documented for children to participate in research unless these requirements are waived by the IRB. In instances where permission of two parents is required, edit the parental permission template to add lines to capture the printed name and signature of the second parent. 

Review the Assent and Parental Permission Policy

Assent Templates

For research involving children, the assent of a child to participate in research is required whenever the child is capable of providing assent, based on the age, maturity, condition, and psychological/emotional state of the child. Documentation of assent is generally required, based on the age and literacy level of the child and the nature of the research. If verbal assent will be obtained, the IRB must review a written description of the information (i.e., a script) that will be provided to the child participants during the assent process.

Assent may also be appropriate for adults with decisional impairment and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent.

Review the Assent and Parental Permission Policy

Consent Addendum Template

A consent addendum may be used for optional sub-studies presented at the start of subject participation or when new information becomes available during the study. This addendum template must be used in conjunction with the consent template.

Short Form Consent Template for Non-English Speaking Participants

Review the Short Form Informed Consent policy for information about using the short form consent process and forms listed below.

Investigators should carefully consider whether sufficient resources exist to assist with questions the participant may have during the informed consent process or during participation in the research before enrolling a non-English speaking participant using the short form consent process.

These translations are available in part through funding from The Ohio State University Comprehensive Cancer Center. Upon demonstrated need, additional short form consent translations may be requested. 

Review the Short Form Informed Consent Policy

Guidance

Waiver of Informed Consent and Waiver of Consent Documentation

DHHS and FDA regulations permit waivers (or alterations) of the consent process if the research meets certain conditions.

Deception, Incomplete Disclosure and Debriefing

Deception

A project involves deception when an investigator gives false information to, or otherwise intentionally misleads, a research participants about some key aspect of the research to avoid biased responses. If participants will be given false information or otherwise misled during a study, then the participants are not provided with all of the required elements of informed consent and IRB approval for a waiver or alteration of informed consent is required. Examples include:

  • Participants are told they scored poorly on a writing assignment completed as part of a study (regardless of how well they actually did) to see how that information influences their performance throughout the remainder of the study.
  • The study involves confederates (individuals who appeared to be research participants but who are actually part of the experiment) who act to manipulate the participant or their environment as part of the study (e.g., Asch’s study of conformity).

Incomplete Disclosure

A project involves incomplete disclosure when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. Not all incomplete disclosure requires a waiver or alteration of consent; however, if material information or aspects are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not provided with all of the required elements of informed consent and IRB approval for a waiver or alteration of informed consent is required. Examples include:

  • A study is vaguely described as a simple economics game to study decision-making in pairs. Participants are not informed that their interactions are actually being recorded and that people are paired according to race in order to study interracial interactions and body language.
  • Participants are only told that they are participating in a simple survey of knowledge, when actually the information contained in the survey is meant to be an intervention/catalyst to see if it causes the participants’ behavior to change between two time points or causes them to take a certain action based on the survey information.

Debriefing

Debriefing is often required when the research involves deception or involves incomplete disclosure of material information/aspects related to the research purpose or activities. In general, the debriefing will explain any deception or incomplete disclosure, provide information about why it was necessary to use deception or incomplete disclosure in the research, and provide other options available to participants (e.g., the ability to withdraw their data). Debriefing is not always required when researchers can provide the IRB with adequate justification for why debriefing is not appropriate.

Tips for Written Informed Consent

  1. Assure that all personnel involved with recruitment and obtaining informed consent have completed training and have been approved by the IRB to participate in the protocol.
  2. Provide a copy of the complete consent document to each participant.
  3. Examine the executed document to ensure that all blanks are completed.
  4. Confirm that the PI/designee signature line has been completed by the person who obtained the participant’s consent.
  5. Retain signed consent forms in hard copy, electronic, or other media form that complies with sponsor, Federal, and university requirements for at least three years after study termination. Note: Individual sponsors may have longer retention requirements.
  6. Insert protocol specific information, including the IRB approval date and version, in the consent form header to ensure that the most recent, IRB‐approved version is used to obtain informed consent (e.g., “01/25/23, Version 3,” third version of the consent form approved by the IRB on 01/25/23).
  7. Correct or update information on the consent form by submitting an amendment for IRB review and approval prior to use (i.e., do not cross through incorrect or outdated information).
  8. Keep a limited number of consent form copies on hand (or print current version directly before starting the informed consent process) to avoid use of unapproved/outdated consent documents.
  9. Use only blue or black ink when completing the consent document.

Resources

Federal Regulations and Guidance

Glossaries

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